A non-randomized, open label, single arm post market clinical study to evaluate effectiveness of a new antimicrobial wound dressing (VELVERT) in diabetic foot ulcer.

Datt Mediproducts Private Limited0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年3月4日

试验速览

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•1. Adult Diabetic male and female subjects of age group between 18 to 65 years. (Both included).
•2. Subjects with Diabetic foot ulcer Stage 2/3, Non- ischemic.
•3. Subjects/ LAR must be able to read and understand informed consent, and can sign the informed consent on patient’s behalf.
•4. Subjects who allow their data to be collected for the study at predefined follow-up periods.
•5. Subject has adequate vascular perfusion of the affected limb, as defined by - Ankle-Brachial Index (ABI) greater than equal to 0.9 and less than equal to 1.2
•6. Ulcer with a size greater than equal to 04 to less than equal to 18 cm (length and breadth) and depth less than equal to 2 cm.
•7. HbA1c greater than equal to 6.5% (diabetic patients).

•1. Subject unwilling or unable to comply with the follow up visits necessary for data collection.
•2. Subject found positive for HIV, HBsAg and HCV.
•3. Concurrent participation in another clinical trial that involves an investigational drug or dressing that would interfere with this study.
•4. Pregnant females.
•5. Subject with Immunosuppression, corticosteroids or chemotherapy.
•6. Subject with decision making impairment.
•7. Subject with a severe comorbid disorder, not expected to survive more than 12 months.
•8. Allergies to any material contained investigational devices.
•9. Subject with ischemic Diabetic foot ulcer.
•10. Subjects with diabetic foot ulcer complications. (Stage 3 and above).
•11. Subjects with gangrene present on any part of the affected foot.
•12. Subjects with burn wounds, malignant ulcers, tubercular ulcers, leprotic ulcers, venous ulcers, gangrenous ulcers, ischemic ulcers, and bed sores.
•13. Subjects with infected wound, not related to Diabetic foot ulcers.
•14. Any other condition which, according to the judgment of the investigator, could interfere in the study.
•15. Restricted blood flow studied through Doppler test.

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